R3 71338554Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010598721), received between Jan 27, 2020 and Oct 16, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K113848, K211176); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A REVISION SURGERY ON (B)(6) 2020 DUE TO DISLOCATION (REPORTED PREVIOUSLY) THEN, PATIENT HAD HEAVY EXUDATING WOUND POST REVISION FOR INSTABILITY, SO PATIENT RECEIVED A WASHOUT AND DEBRIDEMENT WITH SALINE, IODINE AND PEROXIDE. THE R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM AND THE OXINIUM FEM HD 12/14 36 MM XL/+12 WERE REMOVED. SHELL AND STEM RETAINED. WOUND WASHED AND IRRIGATED. NEW IMPLANTS OF THE SAME SIZING WERE IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10693309 ↗
• InjuryFeb 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFERED FROM A DISLOCATION THAT HAD TO BE REDUCED 5 TIMES.

  Patient problems: Injury

  MAUDE report 9712882 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE REVISION DUE INFECTION. ALL THE COMPONENTS WERE REMOVED AND AN ANTIBIOTIC IMPREGNATED PROSTALAC SPACER WAS USED. THE PATIENT WAS RE IMPLANTED WITH A FULL SMITH AND NEPHEW SYSTEM ON (B)(6) 2012.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9634322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
• Z-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.